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Study on the Effectiveness and Safety of HRO350 for Patients with Mild-to-Moderate Psoriasis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for psoriasis, a skin condition that causes red, itchy, and scaly patches. The treatment being tested is called HRO350, which contains a substance known as PEHeRo (phospholipid esters from herring roe oil). The study will compare the effects of two different doses of HRO350 to a placebo in people with mild-to-moderate psoriasis. The goal is to find the most effective dose for future studies.

Participants in the study will take the treatment in the form of soft capsules by mouth. The study will last for several weeks, during which participants will be monitored to see how their psoriasis responds to the treatment. The study will also look at the safety of the treatment and any side effects that may occur. Throughout the study, participants will have regular check-ups to assess their skin condition and overall health.

In addition to HRO350, the study will also involve the use of betamethasone valerate, a common ointment used to treat skin inflammation, as part of the treatment process. The study aims to provide valuable information on the effectiveness and safety of HRO350, helping to determine the best dose for future research and potential use in treating psoriasis. Participants will be closely monitored to ensure their safety and well-being throughout the study.

Who Can Join the Study?

  • You must provide a signed and dated informed consent, which is a document where you agree to participate in the study after being told about all its details.
  • You must be male or female and at least 18 years of age.
  • You must have been diagnosed with chronic, active plaque psoriasis, which is a long-term skin condition that causes raised, red, and scaly patches, and this condition must be mild to moderate in severity.
  • Your psoriasis must have continued for at least 6 months without using systemic treatment, which refers to medications that work throughout your entire body rather than just on the skin surface.
  • Your Psoriasis Area and Severity Index (PASI) score, which is a tool used to measure how much skin is covered and how severe the symptoms are, must be between 3 and 10.
  • Your Body Surface Area (BSA), which is the measurement of how much of your total body skin is affected by the condition, must be at least 3.
  • Your Static Physician’s Global Assessment (sPGA) score, which is a scale used by a doctor to rate the overall severity of your skin condition, must be between 2 and 4.
  • Men and women who are able to have children must agree to use highly effective birth control, such as implants, certain pills, or devices placed in the uterus, throughout the study and for 30 days after finishing the treatment.
  • Women will be considered to have the potential to have children unless they have had surgery to prevent pregnancy, such as a hysterectomy (removal of the uterus) or tubal ligation (closing the fallopian tubes), or if they have not had a period for at least 12 months due to menopause.

Who Cannot Join the Study?

  • You cannot participate if you have used phototherapy, which is a treatment that uses ultraviolet radiation (light rays from the sun or special lamps) to treat skin conditions, within 8 weeks before the study starts or during the study.
  • You cannot participate if you have taken any investigational drug, which is a medicine that is currently being tested in a clinical trial, within 4 weeks before the study starts or during the study.
  • You cannot participate if you have used systemic anti-psoriatic treatment, which are medicines that work throughout your entire body to treat psoriasis, within the last 3 months before the study starts or during the study. For biologics, which are specific types of medicines made from living organisms to target certain parts of the immune system, this period is 6 months.
  • You cannot participate if you have used topical anti-psoriatic treatment, which are creams, ointments, or gels applied directly to the skin, within the last 2 weeks before the study starts.
  • You cannot participate if you have changed any anti-inflammatory medication, which are drugs used to reduce swelling and pain for other long-term illnesses, within the last 4 weeks before the study starts or during the study.
  • You cannot participate if you have taken omega-3 fatty acid supplements or medicines, which are nutrients often found in fish oil, within the last 2 weeks before the study starts or during the study.
  • You cannot participate if you have a known allergy, which is an immune system reaction, to fish or vegetable oils such as soy.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland

Verified Sites

Site Name City Country Status
Evimed Sp. z o.o. Warsaw Poland
Medicover Integrated Clinical Services Sp. z o.o. Bydgoszcz Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Technische Universitaet Dresden Dresden Germany
Hautzentrum Weißensee, Studienzentrum KorSearch Berlin Germany
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak Lodz Poland

Other Sites

Site Name City Country Status
Clinical Research Services Turku CRST Oy Turku Finland
Ko-Med Centra Kliniczne Sp. z o.o. Pulawy Poland
Universitetssykehuset Nord-Norge HF Tromsø Norway
Klinika Osipowicz & Turkowski Sp. z o.o. Warsaw Poland
ProDerma Duelmen Germany
Universitaetsklinikum Erlangen AöR Erlangen Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Harzklinikum Dorothea Christiane Erxleben GmbH Quedlinburg Germany
Helse Stavanger HF Stavanger Norway
Hautarztpraxis Dr. Leitz Und Kollegen Stuttgart Germany
CRST Helsinki Oy Helsinki Finland
MENSINGDERMAresearch GmbH Hamburg Germany
Rosenpark Research GmbH Darmstadt Germany
Nordlandssykehuset HF Bodo Norway
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Klinikum Bielefeld gGmbH Bielefeld Germany
Derma-Study-Center Friedrichshafen GmbH Friedrichshafen Germany
ISA Interdisciplinary Study Association GmbH Berlin Germany
Klinika Ambroziak Sp. z o.o. Warsaw Poland
OHA-Med Sp. z o.o. Warsaw Poland
Medicorium GmbH Friedrichsdorf Germany
Ärztehaus Rudolf Virchow Berlin Germany
Hautmedizin Bad Soden Studienzentrum GmbH Bad Soden Germany
Hinwg Bgkqiw Ht Bergen Norway
Hriax unl Lojinojcbomy Hstorsrmt Dbdwdzbzlxvjpiyd Spdgdumwqlovtn Simmern Germany
Dcjwcekomrge Qmpxe Mainz Germany
Rnnrr Ctqgzl Snz z odcl Bialystok Poland
Unmyghjlrq Hsivvvix Oj Nrgxe Nkzceg Ho Harstad Norway
Ajnqb Hjo Ag Arendal Norway
Mlstcqinf Igzyzypwcv Chwaxqqx Sfbynptf Spu z omwb Warsaw Poland
Hysygqrmrreqra Dq Mts Mfzvrqef Hdzfvtsp Witten Germany
Pfyglf fcw Hduanyajwgd ujs Omckmmiaq Bkcqmf Mmcix Berlin Germany
Syzrdttxydmcrl ay dqb Hlot Grb Bramsche Germany
Lenhgv Mgwoqxwcqt Uxxqnskoma Ol Mllpkn Munich Germany
Umtyylmimjbahqfnciyzq Mmknfary Agn Munster Germany
Gukgxc Ukkmnxamlw Fttftnwmz Frankfurt Germany
Hslcw Mhibl Ow Rcroclc Hd Aalesund Norway
Uigqinhznuifyktvoudof Eossv Avl Essen Germany
Tgxsqdoeutu uag Scureqzugmr Bxodnqoo Gkxz Bad Bentheim Germany
Iogiddvh Zhpupve Di Bovwaxhklasfouuvb Oświęcim Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Not recruiting
01.03.2023
Germany Germany
Not recruiting
01.03.2023
Norway Norway
Not recruiting
01.03.2023
Poland Poland
Not recruiting
01.03.2023

Trial locations

Investigated drugs:

Pehero is an oral medication being tested to see how well it works and how safe it is for people living with mild-to-moderate psoriasis.

Betamethasone valerate is a topical cream used as background therapy to help manage skin symptoms.

Investigated diseases:

Psoriasis – This is a chronic condition that affects the skin by causing cells to multiply much faster than normal. These excess skin cells build up on the surface, forming thick, red, and scaly patches. The affected areas can appear on various parts of the body, such as the elbows, knees, or scalp. As the condition progresses, these patches may become itchy, sore, or cracked. The appearance and severity of these skin changes can fluctuate over time.

Trial ID:
2022-501850-12-00
Protocol code:
HRO350-PS-2B HeROPA
Trial Phase:
Therapeutic exploratory (Phase II)

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